Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,044
- 试验地点
- 1
- 主要终点
- immune response of ESAT6-CFP10 from the size of induration or redness in all population
研究概览
简要总结
The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192 participants whose three kinds of detection result are all negative and are considered as study population II.Then,they are immune to the Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.
详细描述
1.the correlation of three detection methods for study population I
500 study population I are randomly divided into two different dose group on average, according to ESAT6-CFP10 dose(5μg/ml or 10μg/ml). Do specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 and TB-PPD at different arm of the same subject.Evaluate respectively the positive rate of three detection methods 、the correlation of three detection methods and the security of study population I after application for ESAT6-CFP10 .
2.screen study population II
Choose those participants, whose result of three detection (ESAT6-CFP10、TB-PPD andγ-IFN ) all negative, HIV negative and chest X-ray no abnormalities, into study population II.
3.study population II vaccinate BCG or placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
immune response of ESAT6-CFP10 from the size of induration or redness in all population
时间窗: within 72 Hours After Intradermal Injection With ESAT6-CFP10
We measure the size 24h,48h,72h after administered intradermally ESAT6-CFP10
immune response of TB-PPD from the size of induration or redness in all population
时间窗: within 72 Hours After Intradermal Injection With TB-PPD
We measure the size 24h,48h,72h after administered intradermally TB-PPD
the results of specificity γ-IFN test in all subjects
时间窗: before administered intradermally
次要结局
- ESAT6-CFP10 cosistency with γ-IFN in all subjects(within 72 hours after injection)
- TB-PPD cosistency with γ-IFN in all subjects(within 72 hours after injection)
- the Number of Participants With Adverse Events(within 72 hours after injection)
- ESAT6-CFP10 cosistency with TB-PPD in all subjects(within 72 hours after injection)